A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
NCT01989325
ABOUT THIS STUDY
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- Confirmed multiple myeloma with measurable disease.
- Disease refractory to last myeloma regimen.
- Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment.
- Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
- Additional criteria exist.
Key
- Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor.
- Past or current plasma cell leukemia.
- Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and
skin changes).
- Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy
with pain despite appropriate interventions, within 28 days prior to first dose of
study treatment.
- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to
first dose of study treatment.
- Concomitant malignancies or previous malignancies (other than multiple myeloma) with
less than a 2-year disease-free interval at the time of first dose of study treatment.
Patients with adequately resected basal or squamous cell carcinoma of the skin,
carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible
irrespective of the time of diagnosis.
- Known pulmonary hypertension of any severity.
- Concurrent cardiac disease that, in the judgment of the Investigator, would make the
patient inappropriate for study participation.
- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B
and/or hepatitis C.
- Acute active infection requiring treatment.
- Additional criteria exist.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma | ||||||
Official Title ICMJE | Not Provided | ||||||
Brief Summary | This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Advanced Multiple Myeloma | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 77 | ||||||
Original Estimated Enrollment ICMJE | 75 | ||||||
Actual Study Completion Date ICMJE | May 2016 | ||||||
Actual Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01989325 | ||||||
Other Study ID Numbers ICMJE | ARRAY-520-216 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | September 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |